drugset / Trial / NCT03444298
A Study of Gamma Tocopherol-enriched Supplement on Lower Airway Responses to Inhaled Wood Smoke in Healthy Adults
Phase 2
Completed
16 enrolled
University of North Carolina, Chapel Hill
National Institute of Environmental Health Sciences (NIEHS) · collab
RandomizedCrossoverTriple-blindTreatment
Summary
Purpose: To determine the efficacy of 1400 mg gamma tocopherol-enriched supplement for mitigating inhaled wood smoke particle-induced airway inflammation in healthy adults with no more than mild asthma.
Timeline
- Start
- 2018-06-08
- Primary completion
- 2023-03-02
- Completion
- 2023-03-06
Publications
- Background Burbank AJ, Duran CG, Almond M, Wells H, Jenkins S, Jiang Q, Yang C, Wang T, Zhou H, Hernandez ML, Peden DB. A short course of gamma-tocopherol mitigates LPS-induced inflammatory responses in humans ex vivo. J Allergy Clin Immunol. 2017 Oct;140(4):1179-1181.e4. doi: 10.1016/j.jaci.2017.04.030. Epub 2017 May 12. No abstract available.
- Background Hernandez ML, Wagner JG, Kala A, Mills K, Wells HB, Alexis NE, Lay JC, Jiang Q, Zhang H, Zhou H, Peden DB. Vitamin E, gamma-tocopherol, reduces airway neutrophil recruitment after inhaled endotoxin challenge in rats and in healthy volunteers. Free Radic Biol Med. 2013 Jul;60:56-62. doi: 10.1016/j.freeradbiomed.2013.02.001. Epub 2013 Feb 9.
- Background Wiser J, Alexis NE, Jiang Q, Wu W, Robinette C, Roubey R, Peden DB. In vivo gamma-tocopherol supplementation decreases systemic oxidative stress and cytokine responses of human monocytes in normal and asthmatic subjects. Free Radic Biol Med. 2008 Jul 1;45(1):40-9. doi: 10.1016/j.freeradbiomed.2008.03.002. Epub 2008 Mar 12.
- Background Burbank AJ, Duran CG, Pan Y, Burns P, Jones S, Jiang Q, Yang C, Jenkins S, Wells H, Alexis N, Kesimer M, Bennett WD, Zhou H, Peden DB, Hernandez ML. Gamma tocopherol-enriched supplement reduces sputum eosinophilia and endotoxin-induced sputum neutrophilia in volunteers with asthma. J Allergy Clin Immunol. 2018 Apr;141(4):1231-1238.e1. doi: 10.1016/j.jaci.2017.06.029. Epub 2017 Jul 20.
- Results Peden DB, Almond M, Brooks C, Robinette C, Wells H, Burbank A, Hernandez M, Hinderliter A, Caughey M, Jiang Q, Wang Q, Li H, Zhou H, Alexis N. A pilot randomized clinical trial of gamma-tocopherol supplementation on wood smoke-induced neutrophilic and eosinophilic airway inflammation. J Allergy Clin Immunol Glob. 2023 Oct 5;2(4):100177. doi: 10.1016/j.jacig.2023.100177. eCollection 2023 Nov.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gamma Tocopherol | Unknown | 1400 mg | Oral |